<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20090301001722N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Ipsilateral Sacroiliac dysfunction among (Right/Left-hand drive) taxi drivers and effect of sacroiliac belt on muscular activity during sit to unilateral stand task.</public_title>
      <acronym></acronym>
      <scientific_title>Ipsilateral Sacroiliac dysfunction among (Right/Left-hand drive) taxi drivers and effect of sacroiliac belt on muscular activity during sit to unilateral stand task.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The examiner will remain blind about the low back condition who will perform sacroiliac provocative test. During EMG, the investigator will also be bling about the side of involvement of the sacroiliac Joint and low back pain, Blinding description: The examiner will remain blind about the low back condition who will perform sacroiliac provocative test. During EMG, the investigator will also be bling about the side of involvement of the sacroiliac Joint and low back pain.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sacroiliac Joint Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group(A): Before Treatment; EMG would be performed on this group before the application of Sacroiliac belt. Intervention 2: Intervention group(B): After Treatment; EMG would be performed on this group after the application of Sacroiliac belt. Intervention 3: Control group:Based on methodology, EMG would be performed on this healthy group without performing any treatment.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is As per consent form, Researcher was obliged to keep the participants information confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mohammad-Reza Hadian Rasanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrasan@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences (TUMS)-International Campus</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male taxi drivers
Aged between 20-60 years
Work experience of more than one year
willing to cooperate</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having  history of surgery
Acute pathological condition
Radiating pain toward lower limb
Any limb length discrepancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Musculoskeletal disorders - Segmental and somatic dysfunction of sacral region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group(A): Before Treatment; EMG would be performed on this group before the application of Sacroiliac belt.</i_keyword>
      <i_keyword>Intervention group(B): After Treatment; EMG would be performed on this group after the application of Sacroiliac belt.</i_keyword>
      <i_keyword>Control group:Based on methodology, EMG would be performed on this healthy group without performing any treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PAIN. Timepoint: Before &amp; after Treatment ( Immediate effect &amp; Prolong Effect after one month). Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Integrated EMG. Timepoint: Before and  after Treatment. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
      <prim_outcome>Root mean square (RMS). Timepoint: Before and  after Treatment. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
      <prim_outcome>Time to peak. Timepoint: Before and  after Treatment. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
      <prim_outcome>Duration of the muscle activity. Timepoint: Before and  after Treatment. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
      <prim_outcome>Premotor Time. Timepoint: Before and  after Treatment. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Before and after Treatment. Method of measurement: Modified Oswestry Disability.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-11</approval_date>
        <contact_name>Tehran University of Medical Sciences (TUMS)</contact_name>
        <contact_address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
